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临床试验/NCT07029477
NCT07029477已完成不适用

Incentive Spirometry Versus Massage Therapy on the Level of Shoulder Pain and Nausea Among Post Laparoscopic Cholecystectomy Patients

Mansoura University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Shoulder Pain Level & Nausea

研究概览

简要总结

The aim of this study is to:

Evaluate the effect of incentive spirometry versus massage therapy on the level of shoulder pain, and nausea among post laparoscopic cholecystectomy patients.

详细描述

Acute cholecystitis is an inflammation of the gallbladder usually caused by gallstones obstructing the gallbladder neck or cystic duct. It is one of the most common surgical emergency presentations globally. Cholecystectomy was well-known as the surgical care for cholecystitis and the preferred treatment for gallstone disease. Earlier, open cholecystectomy was the gold standard for treatment of cholecystitis. However, open cholecystectomy has been associated with a higher risk of surgical site infection (SSI).

Owing to open surgical procedures complications, the laparoscopic technique has now replaced the open technique in many common surgical procedures, including routine cholecystectomy. Laparoscopic cholecystectomy (LC) is clearly defined as a minimally invasive surgical procedure to remove an inflamed gallbladder resulting from symptomatic cholelithiasis, gallstone, gallbladder masses, or polyps.

Laparoscopic cholecystectomy not only benefits the patient by reducing postoperative pain, discomfort, reducing intraabdominal adhesions, improving cosmetic results, shortening hospital stay, and quickening return to usual activities, but it also benefits the surgeon by improving vision and access to the Calot's triangle. In spite of several blessings of laparoscopic surgical treatment, shoulder pain is considered one of early post laparoscopic symptoms. It seems to have a multifactorial mechanism, but the most reported theory is carbon dioxide gas persistence between the right diaphragm and the hepatic dome that stays inside the abdominal cavity for some times. The surgeon injects CO2 gas into the peritoneum to increase the field of vision dur¬ing cholecystectomy via laparoscopy, this gas causes stretching of the peritoneum and diaphragm, as well as excitation of the phrenic nerve and creation of shoulder pain.

In other words, pain occurs in the scapula through stimulating the phrenic nerve, which originates from the third and fifth cervical nerves (C3-C5) and controls movement and provides sensation in the diaphragm. Postoperative pain can lead to increase heart rate, high blood pressure, and consequently, increase cardiac workload, nausea, vomiting, and ileus.

During laparoscopy, the pneu¬moperitoneum can irritate the vagus nerve, leading to post-operative nausea and vomiting (PONV) which cause delayed discharge, dehydration, wound opening, pulmonary aspiration, patient dissatisfaction, and increased treatment costs. Approximately (50-75%)of patients develop PONV. Prevention and treatment of postoperative pain and control of complications such as nausea and vomiting play an important role in early mobility, improve the quality of surgery, and lead to patient satisfaction, early discharge, and reduce costs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both sexes.
  • •Patients aged between 20 to 60 years.
  • •Patients having the ability to communicate.
  • •Willing to participate in the study.

排除标准

  • •Patients who had postoperative bleeding.
  • •Patients who had postoperative hemodynamic disorders (severe elevation or reduction of blood pressure and shock).
  • •Patients who had postoperative complications requiring mechanical ventilation.
  • •Patients who had respiratory aspiration.
  • •Patients who had a history of drug abuse.
  • •Patients who had previous shoulder pain chronicity
  • •Uncooperative patients or patients unable to understand how to use the incentive spirometry device properly.
  • •Patients whose surgery converted from laparoscopic to open surgery

研究组 & 干预措施

Incentive Spirometry for Postoperative Pain and Nausea

Experimental

Participants in this group received incentive spirometry therapy only.

干预措施: Incentive Spirometry (Device)

Massage Therapy for Postoperative Pain and Nausea

Experimental

Participants in this group received massage therapy only.

干预措施: Massage Therapy (Behavioral)

结局指标

主要结局

Shoulder Pain Level & Nausea

时间窗: Within 12 hours post laparoscopic cholecystectomy

Change in patient-reported shoulder pain and nausea using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain or nausea and 10 indicates the worst possible pain or nausea. Higher scores indicate worse outcomes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Arafat Ali Mohamed

Dr

Mansoura University

研究点 (1)

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